The skeptical cardiologist has been testing the comparative accuracy of two hand-held mobile ECG devices in his office over the last month. I’ve written extensively about my experience with the AliveCor/Kardia (ACK) device here and here. Most recently I described my experience with the Afib Alert (AA) device here.

Over several days I had my office patients utilize both devices to record their cardiac rhythm and I compared the device diagnosis to the patient’s true cardiac rhythm.

Normal/Normal

In 14 patients both devices correctly identified normal sinus rhythm. AFA does this by displaying a green check mark , ACK by displaying the actual recording on a smartphone screen along with the word Normal.

The AFA ECG can subsequently uploaded via USB connection to a PC and reviewed in PDF format. The ACK PDF can be viewed instantaneously and saved or emailed as PDF.

Normal by AFA/Unreadable or Unclassified by AliveCor

In 5 patients in normal rhythm (NSR) , AFA correctly identified the rhythm but ACK was either unreadable (3) or unclassified (2). In the not infrequent case of a poor ACK tracing I will spend extra time adjusting the patient’s hand position on the electrodes or stabilizing the hands. With AFA this is rarely necessary.

In this 70 year old man the AFA device recording was very good and the device immediately identified the rhythm as normal.

ACK recording was good quality but its algorithm could not classify the rhythm.

A 68 year old man who had had bypass surgery and aortic valve replacement had a very good quality AFA recording with correct classification as NSR

AliveCor/Kardia recordings on the same patient despite considerable and prolonged efforts to improve the recording were poor and were classified as “unreadable”

There were 3 cases were AFA diagnosed atrial fibrillation (AF) and the rhythm was not AF. These are considered false positives and can lead to unncessary concern when the device is being used by patients at home. In 2 of these ACK was unreadable or unclassified and in one ACK also diagnosed AF.

A 90 year old woman with right bundle branch block (RBBBin NSR was classified by AFA as being in AF.

Slight irregularity of rhythm combined with a wider than normal QRS from right bundle branch block and poor recording of p waves likely caused AFA to call this afibAliveCor tracing calls this unclassified. The algorithm does not attempt to classify patients like this with widened QRS complexes due to bundle branch block.

The ACK algorithm is clearly more conservative than AA. The ACK manual states:

If you have been diagnosed with a condition that affects the shape of your EKG (e.g., intraventricular conduction delay, left or right bundle branch block,Wolff-Parkinson-White Syndrome, etc.), experience a large number of premature ventricular or atrial contractions (PVC and PAC), are experiencing an arrhythmia, or took a poor quality recording it is unlikely that you will be notified that your EKG is normal.

One man’s rhythm confounded both AFA and AC. This gentleman has had atrial flutter in the past and records at home his rhythm daily using his own AliveCor device which he uses in conjunction with an iPad.

During our office visits we review the recordings he has made. He was quite bothered by the fact that he had several that were identified by Alivecor as AF but in fact were normal.

These are recordings Lawrence made at home that i can pull up on my computer. He makes a daily recording which he repeats if he is diagnosed with atrial fibrillation. In the two cases above of AF a repeat measurement was read as normal. Of the two cases which were unclassified , one was normal with APCs and the other was actually atrial flutter

A recording he made on May 2nd at 845 pm was read as unclassified but with a heart rate of 149 BPM. The rhythm is actually atrial flutter with 2:1 block.

Sure enough, when I recorded his rhythm with ACK although NSR (with APCS) it was read as unclassified

AFA classified Lawrence’s rhythm as AF when it was in fact normal sinus with APCs.

One patient a 50 year old woman who has a chronic sinus tachycardia and typically has a heart rate in the 130s, both devices failed.

We could have anticipated that AC would make her unclassified due to a HR over 100 worse than unclassified the tracing obtained on her by AC (on the right)was terrible and unreadable until the last few seconds. On the other hand the AFA tracing was rock solid throughout and clearly shows p waves and a regular tachycardia. For unclear reasons, however the AFA device diagnosed this as AF.

Accuracy in Patients In Atrial Fibrillation

In 2/4 patients with AF, both devices correctly classified the rhythm..

In one patient AFA correctly diagnosed AF whereas ACK called it unclassified.

This patient was in afib with HR over 100. AFA correctly identified it whereas ACK called in unclassified. The AC was noisy in the beginning but towards the end one can clearly diagnose AF

In one 90 year old man AFA could not make the diagnosis (yellow)

ACK correctly identified the rhythm as AF

One patient who I had recently cardioverted from AF was the only false positive ACK. AliveCor tracing is poor quality and was called AF whereas AFA correctly identified NSR>

Overall Accuracy

The sensitivity of both devices for detecting atrial fibrillation was 75%.

The specificity of AFA was 86% and that of ACK was 88%.

ACK was unreadable or unclassified 5/26 times or 19% of the time.

The sensitivity and specificity I’m reporting is less than reported in other studies but I think it represents more real world experience with these types of devices.

Summary

In a head to head comparison of AFA and ACK mobile ECG devices I found

-Recordings using AfibAlert are usually superior in quality to AliveCor tracings with a minimum of need for adjustment of hand position and instruction.

-This superiority of ease of use and quality mean almost all AfibAlert tracings are interpreted whereas 19% of AliveCor tracings are either unclassified or unreadable.

-Sensitivity is similar. Both devices are highly likely to properly detect and identify atrial fibrillation when it occurs.

-AliveCor specificity is superior to AfibAlert. This means less cases that are not AF will be classified as AF by AliveCor compared to AfibAlert. This is due to a more conservative algorithm in AliveCor which rejects wide QRS complexes, frequent extra-systoles.

Both companies are actively tweaking their algorithms and software to improve real world accuracy and improve user experience but what I report reflects what a patient at home or a physician in office can reasonably expect from these devices right now.

I’ve been evaluating the ability of a mobile hand-held ECG device called AfibAlert to detect atrial fibrillation for the last few weeks.

I found that the device made very reliable and consistent recordings of cardiac rhythm and did a reasonably good job of detecting atrial fibrillation (afib).

The device came in a plastic case with a USB cable for uploading recordings and two metal bracelets which attach to electrodes and provide an alternative recording method.

The device itself is about 6 by 3 by 1 inch.

Recordings are made by placing your thumbs on the silver/siver chloride electrodes

After a few seconds the display in the center will give heart rate and after 45 seconds the
device will make a decision about your rhythm:

If it diagnoses normal sinus rhythm a green check appears and if it diagnoses afib a red telephone appears.

If it is confused you get yellow circular arrows.

As the maker of the device explains:

Lohman Technologies’ patented algorithm analyzes the patient’s heartbeat and the appropriate icon illuminates to show what action is needed. AfibAlert’s® algorithm was validated against 51,000+ ECG strips from the MIT-BIH Atrial Fibrillation Database with known diagnosis. The Afib monitor’s results were excellent, with 94.6% accuracy in detecting the presence of arrhythmias. Each recording produces a 45-second diagnostic quality ECG rhythm strip

The device I tested does not allow you to immediately see the ECG tracing. The recordings are uploaded to a PC via USB cable and then can be viewed as a PDF document.

I made 17 recordings on patients in my office one day. The age range was 50 to 93 years and most patients were able to rapidly and easily grasp the device with thumbs appropriately positioned to make interpretable recordings.

Only 2/17 came back. yellow. In both cases, I repeated the recording and the device was able to make the correct diagnosis. Twice I got the yellow signal on an elderly, partially blind patient who had trouble keeping his thumb on the electrode.

In one case of atrial fibrillation the device correctly identified atrial fibrillation.

In one case of SR with
APCs the device
incorrectly identified afib

Overall the device correctly classified 88% of the tracings. This was superior to the device I normally utilize ( AliveCor/Kardia mobile ECG) in head to head comparison (I’ll present this comparison in a subsequent post).

My bullet points on the AfibAlert device:

-5 stars for Ease of Recording

-5 stars for Quality of recording

In all cases that uploaded, the recordings were very clear and free of artifact. The device did not upload yellow signal events and I presume more artifact is present in these recordings.

-2 stars for Convenience.

I found the software and uploading to be very awkward and slow. The company indicates new software soon to be released along with the ability to interface directly with iPads or smartphones that hopefully will improve this factor.

The inability to instantaneously view the ECG tracings means I cannot use it in my office to screen patients for arrhythmias. However, if a patient is solely using it to determine if afib is present or absent, this information is available right away.

-3 stars for Accuracy.

It does a reasonable job of identifying the patient who is in normal rhythm versus one in atrial fibrillation.

However, like AliveCor and other devices which strictly look at the variability of the pulse, it can be easily fooled by premature beats, especially when they are frequent, and inappropriately classify these as afib resulting in false positives.

In addition, when afib rates are very slow and thus much less variable it is likely AfibAlert will incorrectly classify them as normal thus resulting in false negatives.

False Negatives and False Positives

False negatives result in delayed diagnosis of afib. Patients will be falsely reassured that their rhythm is normal when it is not.

False positives result in needless anxiety and testing/treatment.

If afib monitoring devices are to be successful they have to have a very low frequency of both types of inaccuracy.

The solution to inaccuracy of interpretation, of course, is to have a cardiologist over-read the tracings.

AfibAlert recordings are available online for review by your personal physician after being uploaded. This requires your physician to have an account with AfibAlert. There is no capability for having the recordings over read by an online cardiologist for a charge.

As far as I can tell the device is only available for purchase in the US and only on the AfibAlert website.

Interestingly, you cannot purchase AfibAlert without a prescription from a physician.

Why this is mandated for AfibAlert and not AliveCor is a mystery to me.

Skep Doc.
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